Evidence map›Paper›PMID 32160416›Full record

Trial reportCancer medicine2020

Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results.

Thomas Zilli, Sandra Jorcano, Samuel Bral, Carmen Rubio, Anna M E Bruynzeel, Angelo Oliveira, Ufuk Abacioglu, Heikki Minn, Zvi Symon, Raymond Miralbell

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

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  14. HERMES: Delivery of a Speedy Prostate Cancer Treatment.Clinical oncology (Royal College of Radiologists (Great Britain)) · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 7 countries.

Thomas ZilliGeneva University Hospital, Geneva, Switzerland.ORCID 0000-0002-4784-9883
Sandra JorcanoTeknon Oncologic Institute, Barcelona, Spain.
Samuel BralOnze-Lieve-Vrouwziekenhuis, Aalst, Belgium.
Carmen RubioHospital Universitario HM Sanchinarro, Madrid, Spain.
Anna M E BruynzeelAmsterdam UMC, location VUmc, Amsterdam, the Netherlands.ORCID 0000-0002-7542-8920
Angelo OliveiraPortuguese Institut of Oncology, Porto, Portugal.
Ufuk AbaciogluNeolife Medical Center, Istanbul, Turkey.ORCID 0000-0002-3950-8616
Heikki MinnUniversity Hospital Turku, Turku, Finland.ORCID 0000-0002-5878-4333
Zvi SymonSheba Medical Center, Ramat Gan, Israel.
Raymond MiralbellGeneva University Hospital, Geneva, Switzerland.ORCID 0000-0001-7013-7553
Hospital Quirón Teknon · ESAmsterdam University Medical Centers · NLHospital Universitario HM Sanchinarro · ESInstituto Português de Oncologia Francisco Gentil · PTOnze Lieve Vrouwziekenhuis Hospital · BESheba Medical Center · ILTurku University Hospital · FIUniversity Hospital of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo present the 18 months results from a prospective multicenter phase II randomized trial of short vs protracted urethra-sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer (PCa).

methodsBetween 2012 and 2015, a total of 170 PCa patients were randomized to 36.25 Gy in 5 fractions (6.5 Gy × 5 to the urethra) delivered either every other day (EOD, arm A, n = 84) or once a week (QW, arm B, n = 86). Genitourinary (GU) and gastrointestinal (GI) toxicity (CTCAE v4.0 scale), IPSS, and QoL scores were assessed at baseline, at the 5th fraction (5fx), 12th weeks (12W), and every 6 months after SBRT. The primary endpoint was biochemical control at 18 months and grade ≥ 3 toxicity (including grade ≥ 2 for urinary obstruction/retention) during the first 3 months.

resultsAmong the 165 patients analyzed, the toxicity stopping rule was never activated during the acute phase. Maximum acute grade 2 GU toxicity rates at 5fx were 17% and 19% for arms A and B, respectively, with only 2 cases of grade 2 GI toxicity at 5fx in arm A. At month 18, grade ≥ 2 GU and GI toxicity decreased below 5% and 2% for both arms. No changes in EORTC QLQ-PR25 scores for GU, GI, and sexual domains were observed in both arms between baseline and month 18. Four biochemical failures were observed, 2 in each arm, rejecting the null hypothesis of an unfavorable response rate ≤ 85% in favor of an acceptable ≥ 95% rate.

conclusionsAt 18 months, urethra-sparing SBRT showed a low toxicity profile, with minimal impact on QoL and favorable biochemical control rates, regardless of overall treatment time (EOD vs QW).

Indexed as

Quality of LifeAgedAged, 80 and overFollow-Up StudiesHumansMaleMiddle AgedOrgan Sparing TreatmentsPrognosisProspective StudiesProstatic NeoplasmsRadiosurgeryTime FactorsUrethraoverall treatment timeprostate cancerquality of lifestereotactic body radiotherapyurethra sparing

Identifiers

PMID32160416
PMCPMC7196054
OpenAlexW3011586574

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.